ImmunoCellular Therapeutics has been awarded $19.9 million from the governing Board of the California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, to support the ICT-107 Phase III registration trial in patients with newly diagnosed glioblastoma.
The funding was granted under the CIRM 2.0 program, which is a comprehensive collaborative initiative designed to accelerate the development of stem cell-based treatments for people with unmet medical needs.
ICT-107 is specifically engineered as an immunotherapy that preferentially targets and kills cancer tumor stem cells with the goal of preventing tumor recurrence following standard-of-care treatment.
The Phase III ICT-107 trial, which is slated to begin in the fourth quarter of 2015, will include approximately 120 clinical sites in the U.S., Europe, and Canada. Approximately 400 patients are expected to be recruited.
ImmunoCellular reached agreement with the U.S. FDA on a Special Protocol Assessment relative to the primary and secondary endpoints, as well as the statistical plan for the Phase III trial.
“We share CIRM’s commitment to advancing potential breakthrough stem cell-based therapies to patients with unmet medical needs,” said Andrew Gengos, president and CEO of ImmunoCellular, in a press statement. “Our strategic focus going forward will be on advancing our Stem-to-T-cell immunotherapy platform and pursuing additional related technologies to grow our pipeline – strategies that are key to achieving our goal of building a leading cancer immunotherapy company.”